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Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection

2014-08-27 03:15:56 | BioPortfolio

Summary

Pevion Biotech develops a state-of-the-art vaccine against recurrent vulvovaginal candidiasis (VVC) caused by the pathogenic form of Candida albicans especially in pre-menopausal women of childbearing age with a history of recurrent vulvovaginal candidiasis. This study is designed to evaluate the safety and tolerability of the vaccine, administered by two different routes (intramuscular and intravaginal) as primary endpoint. Immunogenicity will be evaluated as secondary endpoint.

Description

Vaginal candidiasis is very common and may cause serious disorders and considerable costs. The current therapies, based on synthetic compounds, have suffered from the emergence of antifungal drug resistance. Clearly, new strategies to prevent Candida infections are needed.

To date, observations coming from studies in women with recurrent vulvovaginal candidiasis demonstrate that local immunity is more important for protection and clearance of infection than that provided by systemic host defense mechanisms. In mucosal immunity, humoral and cellular factors have been suggested to confer protection. Natural and monoclonal antibodies generated against Candida antigens have been proven to be protective against experimental Candida vaginitis in animal models when given prophylactically or therapeutically. After thorough preclinical testing for safety and efficacy, this is the first human clinical trial, evaluating a candidate Candida vaccine. The recombinantly produced Candida vaccine antigen is attached to influenza virosomes, a clinically validated carrier and adjuvant technology successfully employed for a variety of experimental and commercially available vaccines.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Recurrent Vulvovaginal Candidiasis

Intervention

PEV7A1, PEV7A9, PEV7B2, PEV7B1

Location

CHUV, Vaccine and Immunotherapy Center
Lausanne
Switzerland
1011

Status

Recruiting

Source

Pevion Biotech Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:56-0400

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